510(k) · Cleared
ClearedEnd Expiratory Filter, Model RT020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Oct 4, 2001 after a 387-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 4, 2001
- Review
- 387 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK002839 End Expiratory Filter, Model RT020Fisher & Paykel Healthcare, Ltd. · 2001
- Descendant · cites it directly · 1 of its ownK050927 RT019 Inspiratory/Expiratory FilterFisher & Paykel Healthcare, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK030071 Servo Guard, Model 64 81 290 EH88EMaquet, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK182862 Servo GuardMaquet Critical Care AB · 2019
- Descendant · 2 generations on · 0 of its ownK133666 RT016 Inspiratory FilterFisher & Paykel Healthcare, Ltd. · 2014
Most influential descendants
Showing 4 of 4 · See all- K050927RT019 Inspiratory/Expiratory FilterFisher & Paykel Healthcare, Ltd. · 2005 · cites it directly1descendant
- K030071Servo Guard, Model 64 81 290 EH88EMaquet, Inc. · 2004 · cites it directly1descendant
- K182862Servo GuardMaquet Critical Care AB · 2019 · 2 generations on0descendants
- K133666RT016 Inspiratory FilterFisher & Paykel Healthcare, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002839 | End Expiratory Filter, Model RT020 | Fisher & Paykel Healthcare, Ltd. | 2001 | — |
| +1 | K050927 | RT019 Inspiratory/Expiratory Filter | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| +1 | K030071 | Servo Guard, Model 64 81 290 EH88E | Maquet, Inc. | 2004 | — |
| +2 | K182862 | Servo Guard | Maquet Critical Care AB | 2019 | — |
| +2 | K133666 | RT016 Inspiratory Filter | Fisher & Paykel Healthcare, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050927 (Fisher & Paykel Healthcare, Ltd., 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002839: End Expiratory Filter, Model RT020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002839
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026